title: Development and validation of a rapid, generic measure of disease control from the patient's perspective: the IBD-control questionnaire.
abstract: BACKGROUND
  The use of patient reported outcome measures to support routine inflammatory bowel disease (IBD) care is not widespread and suggests that existing questionnaires lack relevance to day-to-day decisions or are too cumbersome to administer. We developed a simple, generic tool for capturing disease control from the patient's perspective to address these barriers.
  
  
  METHODS
  Development based on literature review, patient focus groups/interviews and a steering group, defining a limited set of generic questions. The 'IBD-Control' questionnaire comprises 13 items plus a visual analogue scale (VAS) (0-100). Prospective validation involved baseline completion of IBD-Control, quality of life (QoL) questionnaire (UK-IBD-Q), EuroQol (EQ-5D), Hospital Anxiety and Depression Score; and clinician assessment (blinded to questionnaire; recording Harvey-Bradshaw Index or Simple Clinical Colitis Activity Index; Global Clinician Rating; treatment outcome).
  
  
  RESULTS
  299 patients returned baseline surveys (Crohn's disease, n=160; ulcerative colitis, n=139) and 138 attended for repeat visits. Completion time (mean; SD): 1 min 15 s; 25 s; Internal consistency: Cronbach's α for all 13 items (0.85); for subgroup of eight questions ('IBD-Control-8'; 0.86). Strong correlation between IBD-Control-8 and IBD-Control-VAS (r=0.81). Test-retest reliability (2 week repeat): intra-class correlation=0.97 for IBD-Control-8 and 0.96 for IBD-Control-VAS. Construct validity: Moderate-to-strong correlations between IBD-Control-8 and IBD-Control-VAS versus activity indices, UK-IBD-Q and EQ-5D (utility) with r values 0.52-0.86. Discriminant validity (mean instrument scores for remission, mild, moderate or severe): p<0.001 (analysis of variance (ANOVA)). Sensitivity to change: Effect sizes: 0.76-1.44.
  
  
  CONCLUSIONS
  The IBD-Control is a rapid, reliable, valid and sensitive instrument for measuring overall disease control from the patient's perspective. Unlike existing patient reported outcome measures, its simplicity, ease-of-use and generic applicability make it a candidate for supporting routine care.
authors.affiliation: Department of Gastroenterology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK Digestive Diseases Centre, Aintree University Hospital NHS Trust, Liverpool, UK.
authors.forename: Keith
authors.initials: K
authors.lastname: Bodger
authors.affiliation: Department of Gastroenterology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK Digestive Diseases Centre, Aintree University Hospital NHS Trust, Liverpool, UK.
authors.forename: Clare
authors.initials: C
authors.lastname: Ormerod
authors.affiliation: Digestive Diseases Centre, Aintree University Hospital NHS Trust, Liverpool, UK.
authors.forename: Daniela
authors.initials: D
authors.lastname: Shackcloth
authors.affiliation: Digestive Diseases Centre, Aintree University Hospital NHS Trust, Liverpool, UK.
authors.forename: Melanie
authors.initials: M
authors.lastname: Harrison
mesh_terms: D000328:Adult; D005240:Feasibility Studies; D005260:Female; D017144:Focus Groups; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000175:diagnosis / Q000628:therapy; D007407:Interviews as Topic; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods*; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data; D010865:Pilot Projects; D011446:Prospective Studies; D011594:Psychometrics; D036301:Qualitative Research; D011788:Quality of Life; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D064232:Visual Analog Scale
keywords: Ibd Clinical; Inflammatory Bowel Disease; Quality Of Life